RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223

RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 is an FDA 510(k)-cleared medical device (K000705) manufactured by Respironics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2000. Regulation: 8.